FDA 483 - Harold D. Hubert, M.D. - July 16, 2021

An FDA inspection of Southeastern Clinical Research Institute in Augusta, GA, revealed a significant issue with investigational drug disposition records. The firm failed to contemporaneously record study drug entries into the Master Drug Accountability log, with dispensed dates being entered months to years after the actual dispensing. This indicates a serious lapse in record-keeping practices for clinical trials.